A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol
Abstract Background Mobile-based screening interventions to detect and treat Major Depressive Disorder (MDD) at an early stage might be a promising approach for reducing its societal burden. In the present study, we will evaluate the feasibility and effectiveness of screening for MDD using a mobile-...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-12-01
|
| Series: | BMC Psychology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40359-024-02230-6 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850253962488315904 |
|---|---|
| author | M. M. E. Zandbergen E. E. L. Jansen L. J. Jabbarian H. J. de Koning I. M. C. M. de Kok |
| author_facet | M. M. E. Zandbergen E. E. L. Jansen L. J. Jabbarian H. J. de Koning I. M. C. M. de Kok |
| author_sort | M. M. E. Zandbergen |
| collection | DOAJ |
| description | Abstract Background Mobile-based screening interventions to detect and treat Major Depressive Disorder (MDD) at an early stage might be a promising approach for reducing its societal burden. In the present study, we will evaluate the feasibility and effectiveness of screening for MDD using a mobile-based screening protocol. Methods This study will be a three-arm, parallel randomized control trial (RCT) performed in a multi-ethnic population within the municipality of Rotterdam (the Netherlands). The trial includes two intervention groups that will be screened 4-weekly for MDD for 12 months using the Patient Health Questionnaire (PHQ-9) and a control group who does not receive mobile-based screening for MDD. Participants in the one-test intervention arm will be referred for further diagnosis and treatment, if necessary, after a single positive test score for moderate-severe major depression symptoms (PHQ-9 > 10). Participants in the multiple-test intervention arm will only be referred after three consecutive positive test scores. 1786 eligible participants will be included in the RCT, with 446 and 447 in the one-test and multiple-test referral arms, respectively, and 893 in the control arm. Primary outcome is participants’ QoL after 12 months (EQ-5D-5L). Secondary outcomes include participants’ QoL after 24 months (EQ-5D-5L), evaluating the occurrence and severity of MDD symptoms (PHQ-9), intervention engagement, and identifying public mental health differences based on sociodemographic characteristics, including age, gender, ethnicity, financial situation, educational background, and living area. Long-term results of the RCT will be incorporated into a microsimulation model to determine the long-term benefits, harms, and costs of MDD screening. Discussion The information gained from examining the feasibility and (cost-) effectiveness of mobile-based screening for MDD could be of guidance for mental health policy implementations and support the introduction of mobile-based screening for MDD in the Netherlands and/or other nations. Trial registration ClinicalTrials.gov: NL84280.078.23, NCT05989412 , August 8, 2024. |
| format | Article |
| id | doaj-art-37ad710c673d4f08b14e185244cc1945 |
| institution | OA Journals |
| issn | 2050-7283 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychology |
| spelling | doaj-art-37ad710c673d4f08b14e185244cc19452025-08-20T01:57:14ZengBMCBMC Psychology2050-72832024-12-011211910.1186/s40359-024-02230-6A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocolM. M. E. Zandbergen0E. E. L. Jansen1L. J. Jabbarian2H. J. de Koning3I. M. C. M. de Kok4Department of Public Health, Erasmus MC, University Medical Center RotterdamDepartment of Public Health, Erasmus MC, University Medical Center RotterdamDepartment of Public Health, Erasmus MC, University Medical Center RotterdamDepartment of Public Health, Erasmus MC, University Medical Center RotterdamDepartment of Public Health, Erasmus MC, University Medical Center RotterdamAbstract Background Mobile-based screening interventions to detect and treat Major Depressive Disorder (MDD) at an early stage might be a promising approach for reducing its societal burden. In the present study, we will evaluate the feasibility and effectiveness of screening for MDD using a mobile-based screening protocol. Methods This study will be a three-arm, parallel randomized control trial (RCT) performed in a multi-ethnic population within the municipality of Rotterdam (the Netherlands). The trial includes two intervention groups that will be screened 4-weekly for MDD for 12 months using the Patient Health Questionnaire (PHQ-9) and a control group who does not receive mobile-based screening for MDD. Participants in the one-test intervention arm will be referred for further diagnosis and treatment, if necessary, after a single positive test score for moderate-severe major depression symptoms (PHQ-9 > 10). Participants in the multiple-test intervention arm will only be referred after three consecutive positive test scores. 1786 eligible participants will be included in the RCT, with 446 and 447 in the one-test and multiple-test referral arms, respectively, and 893 in the control arm. Primary outcome is participants’ QoL after 12 months (EQ-5D-5L). Secondary outcomes include participants’ QoL after 24 months (EQ-5D-5L), evaluating the occurrence and severity of MDD symptoms (PHQ-9), intervention engagement, and identifying public mental health differences based on sociodemographic characteristics, including age, gender, ethnicity, financial situation, educational background, and living area. Long-term results of the RCT will be incorporated into a microsimulation model to determine the long-term benefits, harms, and costs of MDD screening. Discussion The information gained from examining the feasibility and (cost-) effectiveness of mobile-based screening for MDD could be of guidance for mental health policy implementations and support the introduction of mobile-based screening for MDD in the Netherlands and/or other nations. Trial registration ClinicalTrials.gov: NL84280.078.23, NCT05989412 , August 8, 2024.https://doi.org/10.1186/s40359-024-02230-6Randomized controlled trialMajor depressive disorderScreening InterventionsPublic Mental HealthPatient Health Questionnaire-9 |
| spellingShingle | M. M. E. Zandbergen E. E. L. Jansen L. J. Jabbarian H. J. de Koning I. M. C. M. de Kok A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol BMC Psychology Randomized controlled trial Major depressive disorder Screening Interventions Public Mental Health Patient Health Questionnaire-9 |
| title | A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol |
| title_full | A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol |
| title_fullStr | A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol |
| title_full_unstemmed | A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol |
| title_short | A mobile-based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder: study protocol |
| title_sort | mobile based randomized controlled trial on the feasibility and effectiveness of screening for major depressive disorder study protocol |
| topic | Randomized controlled trial Major depressive disorder Screening Interventions Public Mental Health Patient Health Questionnaire-9 |
| url | https://doi.org/10.1186/s40359-024-02230-6 |
| work_keys_str_mv | AT mmezandbergen amobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol AT eeljansen amobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol AT ljjabbarian amobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol AT hjdekoning amobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol AT imcmdekok amobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol AT mmezandbergen mobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol AT eeljansen mobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol AT ljjabbarian mobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol AT hjdekoning mobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol AT imcmdekok mobilebasedrandomizedcontrolledtrialonthefeasibilityandeffectivenessofscreeningformajordepressivedisorderstudyprotocol |